evusheld assessment real world effectiveness in israel clalit health services

Conditions: SARS-CoV-2; COVID-19

Summary: an astrazeneca-sponsored observational, electronic healthcare record (ehr)-embedded retrospective cohort study to assess the real-world effectiveness of evusheld against sars-cov-2 infection, covid-19-related hospitalization, and other covid-19 related outcomes in the total evusheld eligible patient population in the clalit health services in israel.

this a phase iv observational, secondary data study to assess the effectiveness of evusheld in preventing covid-19 infection and severe outcomes using the electronic medical records from the nationwide integrated health system. the study is designed as an astrazeneca-sponsored observational, electronic healthcare record (ehr)-embedded retrospective cohort study to assess the real-world effectiveness of evusheld against sars-cov-2 infection, covid-19-related hospitalization, and other covid-19 related outcomes in the total evusheld eligible patient population in the clalit health services in israel.

Eligibility criteria:
individuals who meet all criteria below will be included. the eligibility criteria aligns with the guidelines of the israeli ministry of health inclusion criteria: * aged 12 years and older as of the date of receipt of evusheld * no record of infection or sars-cov- hospitalization within last 90 days prior to the index date * individuals who are moderate/severe immune compromised due to a medical condition or receipt of immunosuppressive medications or treatments and may mount an adequate immune response to covid-19 vaccine: * hypogammaglobinemia patients regularly treated with immunoglobulins * patients treated with b-cell depleting therapy, including for example such anti-cd20 as rituximab, obinatuzumab, ofatumumab, veltuzumab, y-ibritumomab tiuxetan or ocrelizumab, even without malignant disease, up to six months from treatment. * patients that are treated with b-cell depleting therapy (i.e. anti cd20, rituximab, y-ibritumomab tiuxetan, veltuzumab, ofatumumab, obinatuzumab, ocrelizumab), without a malignant disease * bone marrow transplant (up to a year from the bmt) from outside donors, or with gvhd grades 3-4. * bone marrow transplant (up to a 6 months after the bmt) from self * patients after (car) t-cell therapy (chimeric antigen receptor t-cell therapy) up to 6 months from the treatment. * lungs transplant recipients * solid organ transplant recipients (who has any kind of transplant) or those who received atg (anti thymocyte globulin) over the last 6 months * patients with aggressive lymphoma. * multiple myeloma patients that have active disease, and on treatment at the time of study initiation. individuals who meet the criterion below will be excluded: per the current fda eua, individuals currently infected with sars-cov-2 are not eligible for evusheld as prep. therefore, in the main analysis, individuals who meet the following criteria will also be excluded. exclusion criteria: * with evidence of covid 19 (i.e., a positive diagnostic test, or covid-19 diagnosis code) in the period of 90 days before (pseudo) index date or * with evidence of sars-cov-2 infection on the (pseudo) index date or anytime within the 6-day period immediately following this date (i.e., index date to index date+6)

Keywords: sars-cov-2 covid-19 immunocompromised patients pre-exposure prophylaxis against covid-19 evusheld